FDA Medical devices recall ·

smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter… recall

Recall number
Z-0466-2025
Date
(initiated June 26, 2024)
Company / brand
Smiths Medical ASD, Inc.
6000 Nathan Ln N, Minneapolis, MN, United States
Category
Medical devices › Class II
Classification
Class II
Status
Ongoing
Units affected
156,400 AC adapters
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps

Why was it recalled?

The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate from the input plug.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Model 21-0270-25, UDI/DI 15019517126844, All lots

Distribution

Worldwide distribution.

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0466-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.